BEUDAMED
    FDA Adverse Event Injury Summary report: N

    12MM/130 DEG TI CANN TFNA 380MM/RIGHT-STERILE

    MDR report key: 6789926 · Received August 11, 2017

    Report

    Report Number
    1719045-2017-10767
    Event Type
    Injury
    Date Received
    August 11, 2017
    Report Date
    July 27, 2017
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HSB
    PMA / PMN Number
    K131548
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). PATIENT WEIGHT IS NOT AVAILABLE FOR REPORTING. DATE OF NON-UNION IS NOT KNOWN. (B)(4). COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. DHR REVIEW WAS CONDUCTED. MANUFACTURING LOCATION: (B)(4). MANUFACTURING DATE: 09-DEC-2015 EXPIRATION DATE: 30-NOV-2025 PART #: 04.037.258S, LOT#: 9957270 (STERILE) - QUANTITY 6. INSPECTION SHEET FOR IN-PROCESS/INSPECT DIMENSIONAL/FINAL AND INSPECTION SHEET - TFNA ASSEMBLY INSPECTION MET INSPECTION ACCEPTANCE CRITERIA. COMPONENT PARTS REVIEWED: 04.037.942.2 - LOCK PRONG 130 DEGREE, TFNA LOT - 9660851, 04.037.912.4 - WAVE SPRING, SHIM ENDED LOT - 7921051, 04.037.912.3 - TFNA LOCK DRIVE LOT - 9940950, 21127 - RAW MATERIAL LOT ¿ 9814907. RAW MATERIAL RECEIVED FROM (B)(4). CERTIFICATE OF ANALYSIS RECEIVED FROM (B)(4), MEET SPECIFICATION. RAW MATERIAL RECEIVING/PUTAWAY CHECKLIST MEET REQUIREMENTS. NO NCRS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. ¿STERILITY DOCUMENTATION WAS REVIEWED AND DETERMINED TO BE CONFORMING.¿ DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    IT WAS REPORT THAT THE PATIENT HAD ORIGINAL SURGERY ON (B)(6) 2016 FOR TREATMENT OF A FEMUR FRACTURE WERE THE SURGEON USED THE (TFNA) TROCHANTERIC FIXATION NAIL ADVANCED IMPLANTS. PATIENT WAS IMPLANTED WITH ONE (1) TFNA 12MM/130 DEG TI CANNULATED NAIL, ONE (1) LAG SCREW AND THREE (3) DISTAL LOCKING SCREWS. ON AN UNKNOWN DATE, POST-OPERATIVE, PATIENT PRESENTED WITH A NON-UNION AT THE INTERTROCHANTERIC DISTAL THIRD PORTION OF THE FEMUR BONE. ON (B)(6) 2017, SURGEON REMOVED ALL IMPLANTS AND REVISED THE PATIENT TO A COMPETITOR¿S NATURAL NAIL. IT WAS REPORTED THAT NO FRAGMENTS WERE GENERATED DURING IMPLANT REMOVAL. REVISION SURGERY WAS COMPLETED SUCCESSFULLY WITH NO TIME DELAY. PATIENT IS REPORTED IN STABLE CONDITION. THIS REPORT IS FOR ONE (1) 12MM 130 DEGREE CANNULATED TFNA NAIL/RIGHT THIS IS REPORT 1 OF 5 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    567856 12MM/130 DEG TI CANN TFNA 380MM/RIGHT-STERILE ROD,FIXATION,INTRAMEDULLARY HSB SYNTHES MONUMENT 9957270

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention